There are times when a manufacturer may consider using a clean space rather than a cleanroom. Be it for economic advantages or process flow, there are times when this is a feasible substitute. How do you know if this is the case for you?
Before you look at any other factors, you first need to determine what your customer expects. If he or she has contractual requirements for a cleanroom, then that is what you must deliver. Additionally, what perceptions will the customer have of your clean space? Even if there is no formal request for a cleanroom, is the customer expecting the product be made in an independent, confined space? Know exactly what you have to provide.
If it’s acceptable for you to use a clean space over a cleanroom, here is what you need to consider:
Define everything. Detail the … Read More »
Just because your staff works together on the same project does not mean they will function as a true team. Each person has to share the same goals, motivation, and sacrifice. Follow these five steps to ensure that you choose a team who works together successfully and efficiently:
Combine talent. While assembling a group of talented people will not guarantee success, it is the only way to achieve it. Think about which key players are needed to accomplish your goal. If choosing between candidates, consider how the strengths of each would best support the team.
Drive all motivation around clearly defined goals. Whether you have one long-term goal or several short-term goals, make sure everyone is working towards the same thing. Unite them in their mission to achieve every step of success.
Identify the shared success that will benefit each member. This team … Read More »
There are two primary methods to produce water-for-injection (WFI) for cleanroom applications: multiple-effect distillation and vapor compression. Each method offers different advantages. Here are some key features to consider when determining the right WFI for you:
The breaking point for ROI is 600 gallons/hour. The capital cost of vapor compression is higher than multiple-effect. However, this additional cost breaks even at 600 gph or more. Vapor compression costs $10-12 per 1000 gallons at this rate compared to $18-$25 using multiple-effect. Any lower than 600 gph, however, and vapor compression does not provide a desirable return.
Your facility’s required volumes of clean utilities make a difference. When there’s only a small need for USP, you can couple a vapor compression unit with minimal pretreatment and use the WFI for both applications. If you have a small pure steam requirement, multi-effect can be … Read More »
Relative humidity is a fickle issue in your cleanroom. Both outdoor and indoor factors affect it. Too much humidity will increase particulates and provide a breeding ground for biological contaminants. Too little humidity creates electrostatic discharge. Both instances can cause serious damage to your product and environment.
The ideal humidity is right around 50 percent. Humans thrive in 40-60%. Viruses, mold, bacteria, and fungi flourish above 60%. ESD is minimized right at 50%, and particle adhesion issues are unimportant at 50% and below. Controlling humidity is a mater of accurately measuring it. There are many factors that can disrupt the accuracy of your readings. Here are a couple ways to ensure your measurements are right.
Choose the best equipment.
You need the equipment to perform over an extended period of time. For this reason, performance claims on equipment are not always reliable. You … Read More »
When it comes to your cleanroom, safety is multifaceted. Safety programs use OSHA standards, internal company requirements, and national consensus standards to ensure that work is performed ergonomically, efficiently, and safely. These programs are designed to protect employees and the integrity of the cleanroom. Your cleanroom safety plan should address appropriate employee behavior, functionality of the cleanroom, and cleaning/maintenance of the controlled environment.
Here is what you should include in your plan.
Safety begins with employee hygiene and body/skin/hair care products. Each work day, employees should remember to:
Brush teeth and hair
Reduce skin flakes by using non-silicone skin moisturizers
Avoid make-up, hair product, perfumes, and any aromatic after shaves or lotions
You should already have a gowning procedure in place for employees. This should be reiterated in your safety program. Depending on your cleanroom class, this may include things like:
Secure hoods and masks … Read More »